BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 11784107 · Received May 6, 2021

    Report

    Report Number
    2024168-2021-03853
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    March 12, 2021
    Report Date
    August 25, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SUTURE BREAK WAS NOT CONFIRMED; HOWEVER A NEEDLE TO CUFF MISS WAS OBSERVED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO AN INTERACTION OF THE DEVICE WITH PATIENT ANATOMY OR INABILITY TO MAINTAIN POSITION/STABILITY OF THE DEVICE DURING DEPLOYMENT DUE TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE. D4: LOT NUMBER CORRECTED FROM 0111641 TO 1011841, MANUFACTURING DATE. H4: EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL FIVE PROGLIDE DEVICES REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WITH PROGLIDE DEVICES WAS ATTEMPTED IN THE RIGHT COMMON FEMORAL ARTERY VIA AN 8FR SHEATH USING THE PRE-CLOSE TECHNIQUE PRIOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. REPORTEDLY, A SUTURE BREAK OCCURRED WITH SIX PROGLIDE DEVICES. THE SHEATH WAS UPSIZED TO GREATER THAN AN 10FR AND THE PCI PROCEDURE WAS COMPLETED. MANUAL ARTERIAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683006 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB ABBOTT VASCULAR 1011841

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 8FR, HEPARIN| SHEATH: 8FR, HEPARIN